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Special Drug Use Investigation for PAXIL (Paroxetine) Social Anxiety Disorder (Long-term)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01376271
First received: June 9, 2011
Last updated: June 30, 2014
Last verified: June 2014
  Purpose
The study is designed to evaluate the safety and efficacy of paroxetine on the long-term use in Japanese Social Anxiety Disorder (SAD) subjects.

Condition Intervention
Social Phobia
Drug: Paroxetine

Study Type: Observational
Official Title: Special Drug Use Investigation for PAXIL (Paroxetine) Social Anxiety Disorder (Long-term)

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • The number of adverse events in Japanese subjects with social anxiety disorder treated with paroxetine tablets [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Enrollment: 600
Study Start Date: January 2010
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Subjects prescribed paroxetine tablets
Subjects with SAD prescribed paroxetine tablets during study period
Drug: Paroxetine

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All subjects diagnosed as having social anxiety disorder (SAD) are to be given paroxetine tablets according to the prescribing information
Criteria

Inclusion Criteria:

  • Subjects who are diagnosed as having SAD
  • Subjects who are expected to use paroxetine tablets for the first time

Exclusion Criteria:

  • Subjects taking pimozide
  • Subjects taking monoamine oxidase (MAO) inhibitor or within two weeks after discontinuation of MAO inhibitor
  • Subjects with hypersensitivity to paroxetine
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01376271

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01376271     History of Changes
Other Study ID Numbers: 114102 
Study First Received: June 9, 2011
Last Updated: June 30, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Anxiety Disorders
Phobic Disorders
Mental Disorders
Paroxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 23, 2016